Kornimate/medical-research-clean huggingface dataset:
study evaluating on-demand treatment with benefix in chinese subjects

Conditions: Hemophilia B

Summary: this study will evaluate the safety and efficacy of on-demand treatment with benefix in chinese hemophilia b subjects.


Eligibility criteria:
inclusion criteria: * subjects equal or more than 6 years of age with mild, moderate or severe hemophilia b (fix activity: more than 5%, 1-5%, or less than 1%, respectively) * subjects with previous exposure to fix replacement therapy * if hiv positive, documented cd4 count more than 200/µl within 6 months of study entry exclusion criteria: * diagnosed with any bleeding disorder in addition to hemophilia b * current fix inhibitor or history of fix inhibitor (defined as \>uln of the reporting laboratory) * subject has no history of exposure to fix products (previously untreated patient \[pup\]) * subject is currently utilizing primary fix prophylaxis * subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry * treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation * participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation * subjects with a known hypersensitivity to hamster protein * significant hepatic or renal impairment (alt and ast \>5 x uln, bilirubin \>2 mg/dl or serum creatinine \>1.25 x uln) * prothrombin time \>1.5 x uln * platelet count \<80,000/µl * pregnant or breastfeeding women * unwilling or unable to follow the terms of the protocol * any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the investigator or sponsor

Keywords: on-demand treatment hemostatic efficacy factor ix activity factor ix recovery factor ix inhibitor chinese
study of gastro-oesophageal reflux in patients having had bariatric surgery

Conditions: Gastroesophageal Reflux

Summary: obesity surgery has become commonplace nowadays. this type of surgery is in full swing and although it is mostly beneficial for the health of the patient (reduction of cardiovascular risks, improvement of self image, reduction of osteo-articular risks, etc...) it is however associated with risks. there are several short and long term complications, excluding the ones related to the anesthesia and the post-op recovery: fistulas, abcesses, infections, dysphagia, risks of endobrachyoesophagus, etc... the gastroœsophageal reflux remains by far the most common post-op complaint within patients. patients can experience symptoms as far as 3 years after the surgery. medical treatment alone can in most cases lighten the symptoms. however, in some cases, this treatment fails and another type of surgery (bypass) must be undertaken, which is psychologically traumatic for the patient. this retrospective study will analyze a cohort of patients who underwent bariatric surgery (mainly sleeve gastrectomy), in order to identify those at risk of developping gastroœsophageal reflux and how this complication can be avoided in pre-op. the study will also identify cases of invalidating gastroœsophageal reflux that can be solved by obesity surgery.


Eligibility criteria:
inclusion criteria: * all patients who had at least 1 year of postoperative follow-up exclusion criteria: * patients who did not have postoperative gastroœsophageal reflux * patients who stopped their postoperative follow-up * patients with unsufficient data collection

Keywords: gastroœsophageal reflux sleeve gastrectomy
dose-ranging study to assess safety and efficacy of sp-333 for the treatment of opioid-induced constipation (oic)

Conditions: Constipation

Summary: the purpose of this study is to evaluate the safety and efficacy of a range of oral sp-333 doses for the treatment of opioid-induced constipation (oic) in adults with non-cancer pain taking opioids.


Eligibility criteria:
inclusion criteria: * must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening * must have active oic at screening * active oic must be confirmed during baseline screening bowel habit and symptom diary * must be on stable diet exclusion criteria: * has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction) * use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative) * has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years * unstable thyroid disease

Keywords: constipation opioid gc c agonist pain
robot-assisted d2 distal gastrectomy following neoadjuvant chemotherapy for locally advanced gastric cancers

Conditions: Gastric Cancer

Summary: to evaluate the safety of robot-assisted radical gastrectomy with d2 lymph node dissection in postoperative complications in patients with neoadjuvant chemotherapy for gastric cancer (ct3-4a, n+, m0).


Eligibility criteria:
inclusion criteria: age from over 18 to under 75 years; primary gastric adenocarcinoma (including pap, tub, muc, sig, and por) confirmed pathologically by endoscopic biopsy; ct3-4a, n-/+, m0 according to the ajcc 8th cancer staging manual; without peritoneal metastasis (examined by laparoscopic examination); radical resection (r0) through distal subtotal gastrectomy with d2 lymphadenectomy is anticipated; performance status 0 or 1 (eastern cooperative oncology group) ; asa (american society of anesthesiology) score ≤ 3; normal hemodynamic indices: blood cell count: hb ≥ 90g/l, anc ≥ 1.5×109/l, plt ≥ 80×109/l; liver and renal function: bil\<1.5 times of the upper limit of normal reference values, alt and ast\<2.5 times of the upper limit of normal reference values, and crea≤1 time of upper limits of normal reference values. therapeutic response rating after neoadjuvant chemotherapy is cr, pr, sd, or therapeutic response rating after neoadjuvant chemotherapy is pd, tumor is expected to have radical resection; subjects are still willing to continue participating in this clinical trial. exclusion criteria: history of upper abdominal surgery (include endoscopic mucosal resection or endoscopic submucosal dissection, except for laparoscopic cholecystectomy); history of acute pancreatitis; enlarged or bulky regional lymph node (diameter\>3cm) by imaging exam; patients have received neoadjuvant therapy prior to screen work; history of other malignant disease within the past five years; history of cerebrovascular accident within the past six months; history of continuous systematic administration of corticosteroids within the past month; scheduled simultaneous surgery for other disease; emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer; pyloric obstruction; fev1\<50% of predicted value; women who are pregnant or lactating at the time of screening; severe mental disorder; participating in other clinical studies; refused to sign the informed consent; therapeutic response rating after neoadjuvant chemotherapy is pd, involvement of adjacent structures(t4b), distal metastasis(m1), or enlarged or bulky regional lymph node (diameter\>3cm) by preoperative imaging patients cannot complete 3 cycles of chemotherapy due to intolerance; after 3 cycles of neoadjuvant chemotherapy, patients cannot tolerate surgery due to severe adverse reactions, or asa score ≥ 4 ; patients undertake emergency operation due to tumor bleeding, perforation or obstruction during chemotherapy; after signing the informed consent, the patient withdraws from this clinical trial.
a study of terlipressin in patients with hepatorenal syndrome type 1

Conditions: Hepatorenal Syndrome Type 1

Summary: this is an open-label, multi-center study, investigating the efficacy and safety of terlipressin in japanese patients with hepatorenal syndrome type 1.


Eligibility criteria:
inclusion criteria: - patients who were diagnosed with hrs type 1 according to the diagnostic criteria of hrs and whose serum creatinine value (scr) doubled at 2.5 mg/dl or greater within 2 weeks or whose 24h creatinine clearance (ccr) decreased by half at less than 20 ml/min. patients should meet all the following 5 criteria: \[modified international ascites club's diagnostic criteria of hrs\] 1. chronic or acute liver disease with advanced hepatic failure and portal hypertension. 2. low glomerular filtration rate (scr \>1.5 mg/dl or 24h ccr \<40 ml/min) 3. absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug 4. no sustained improvement in renal function (decrease in scr to 1.5 mg/dl or less or increase in 24h ccr to 40 ml/min or more) following diuretic withdrawal and expansion of plasma volume with 1,500 ml/24h of isotonic saline for 24 to 48h. 5. protein urea \<500 mg/dl, and no ultrasonographic evidence of obstructive uropathy or parenchymal renal disease * age; 20 to 79 years exclusion criteria: * cr value ≥5 mg/dl * child-pugh score ≥14 * fulminant hepatitis * septic shock * hepatocellular carcinoma that does not meet the milan criteria * acute renal failure caused by contrast medium * chronic renal failure * bradycardia (heart rate \<50/min) * hyponatraemia (serum na \<120 meq/l) * ischemic heart diseases (angina pectoris, myocardial infarction), heart failure or clinically relevant arrhythmia * poor-controlled hypertension * arteriosclerosis obliterans or peripheral vascular disorder * cerebrovascular disorder * respiratory diseases such as chronic obstructive pulmonary disease * pregnant or possibly pregnant women and patients who or whose partner desire -pregnancy during the study period * patients considered by the investigator or sub-investigator as unsuitable to participate in the study
s3 root pulsed radiofrequency added to superior hypogstric plexus block

Conditions: Pain Cancer; Pain, Chronic

Summary: the investigators hypothesis that adding pulsed radiofrequency neuromodulation at s3 nerve root to superior hypogastric plexus chemical neurolysis improves analgesia in patients with chronic pelvic cancer pain.


Eligibility criteria:
inclusion criteria: * pelvic cancer patients * with pelvic pain not responding to oral analgesic medications * side effects of oral analgesic medications exclusion criteria: * patients with metastatic cancer disease * patients with significantly impaired organ functions * patients with bleeding diathesis * patients with mental disabilities

Keywords: pelvic cancer pain superior hypogastric plexus block pulsed radiofrequency
the association between blood's and urinary heavy metal level in pregnant women and the spontaneous abortion

Conditions: Heavy Metal Toxicity; Spontaneous Abortion

Summary: the aim of the study was to define the possible association between heavy iron level and the consequence of pregnancy especially spontaneous abortion and missed abortion. the study population will comprised the first-trimester pregnant women in the pumch (peking union medicine college hospital) during 2017 october to 2018 november. we categorised the patients into two groups, the study group where the patients suffered from spontaneous abortion or missed abortion, and the control group where the patients carry the normal live fetal for at least 8 weeks and ask for artificial abortion. all the cases included in the study were examined with respect to 6 kinds of heavy iron level in venous blood and urine, then correlation analysis was applied to define heavy iron level between two groups.


Eligibility criteria:
inclusion criteria: - early trimester pregnant women exclusion criteria: -
study of universal screening for lynch syndrome in chinese patients of endometrial cancer

Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis; Endometrial Neoplasms

Summary: in patients diagnosed as endometrial cancer by thorough pathologic examinations, lynch syndromes are screened by (1)immunohistochemical staining (for mlh1, msh2, msh6 and pms2), (2) tests of microsatellite instability and (3) clinical criteria (amsterdam i or ii criteria and bethesda criteria). for patients with any suspicious discoveries of lynch syndromes from aforementioned screening methods, a molecular diagnosis with next-generation sequencing for mismatch repair genes (mlh1, msh2, msh6, pms2, and epcam) is given to confirm lynch syndromes. for patients of lynch syndromes and endometrial cancer, relatives of blood lineage are tested by sanger method or qpcr to find out carriers of mutation genes of lynch syndromes.


Eligibility criteria:
inclusion criteria: * survivals of endometrial cancer exclusion criteria: * metatatic malignacies to uterine * leiomyosarcoma of uterus
effect of protein source during ketogenic weight loss intervention

Conditions: Obesity; Obesity; Endocrine

Summary: this randomized, controlled, single-blinded study will investigate how the protein source in a high-protein ketogenic diet affects metabolic weight loss outcomes after a 12-week dietary intervention

this randomized, controlled, single-blinded study will compare how a ketogenic weight loss diet, supplemented with either animal- or plant-based protein affects: (i) metabolic markers (adipokine and cytokine) in adipose tissue and blood, (ii) adipose tissue immune cell profiles, and (iii) adipocyte characteristics and their interaction with other cells (e.g. immune cells and muscle cells). to better determine how tissue characteristics affect the whole body level, the relationships between adipose tissue characteristics and blood lipid and inflammatory markers will also be examined. participants undergo anthropometric measurements, questionnaires, body composition assessment, energy assessment, blood draws, and adipose tissue biopsies from the abdominal and femoral adipose tissue depots

Eligibility criteria:
inclusion criteria: * adults between 18-60 years old * bmi: \>29.99kg/m2 exclusion criteria: * any chronic metabolic conditions (e.g. cvd) * renal impairment (creatinine clearance \<60 ml/min) * uncontrolled hypothyroidism * pregnant, breastfeeding, or postmenopausal females * past (\<6 year) or present use of nicotine products * use of cannabis products * use of any other medications that may affect study outcomes (e.g. anti-depressants) * participants who have had a number of ct scans in the course of the year * participants following a vegan diet
clinical studies of new model haploidentical hematopoietic stem cell transplantation

Conditions: CD19-chimeric Antigen Receptor T Cells; Relapsed and/or Refractory Acute Lymphoblastic Leukemia; the Haploidentical Hematopoietic Stem Cell Transplantation

Summary: building a new haploid transplanted model with high-dose ctx、cd19-cart,donor cd34+ hematopoietic stem cell and tregs,to prevent graft-versus-host disease(gvhd),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（gvl）and gvhd，then to reduce the relapse rate after hematopoietic stem cell transplantation（hsct）for relapsed and/or refractory b cell acute lymphoblastic leukemia（r/r-b-all）.

compare the new haplo-hsct model with the traditional haplo-hsct in dfs、os、rfs、cr and the degree of gvhd.etc.for the r/r b-all patients.

Eligibility criteria:
inclusion criteria: 1. the r/r b-all patients 2. have the healthy allo-hsct donor 3. voluntary and signed the treatment protocol exclusion criteria: 1. not match the inclusion criteria 2. important organ is dysfunction, such as heart and/or renal dysfunction,liver failure 3. pregnancy or breast-feeding women 4. has virus infection,such as hiv,hepatitis virus,and can not be cleared with anti-virus treatment
safety and diagnostic performance of upar pet imaging in localised, untreated prostate cancer

Conditions: Prostate Cancer

Summary: the goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer (biopsy-verified isup grade). the aim is that the diagnostic pet imaging agent may be used as an alternative or supplement to biopsies in the monitoring of patients with low-risk prostate cancer in active surveillance. patients diagnosed with untreated, low-grade, localized prostate cancer may participate in the trial. the experimental diagnostic agent 64cu-dota-ae105 is a radiopharmaceutical which is injected into the veins and binds to upar expressing cells in the tumour which can then be visualized in a pet scanner. the main question the trial aims to answer is: can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer? the trial is divided in 2 parts: * participants in the first part will receive 2 injections of test drug on 2 different days. * the first day the participant will receive an injection of the test drug and then be asked to lie down in the pet/ct scanner so that images of the prostate can be taken. before and after the injection/scanning procedure the participant will have tests done. these tests will include evaluation of health status, measurement of heart function by ecg plus blood and urine samples. * after 8 days the procedures, including injection of test drug and scanning, will be repeated. * participants in the second part of the trial will only have 1 injection of the test drug and subsequent pet/ct scanning. like in part 1 of the trial, tests will be done before and after the injection/ scanning procedure.


Eligibility criteria:
inclusion criteria: * pathology-verified prostate adenocarcinoma * international society of urological pathology (isup) grade 1 to 3 * localised prostate cancer (n0 and m0 status) (only required for isup 3 patients) 1. newly diagnosed patients: staging must be performed within 6 months from enrolment into the trial. 2. active surveillance: n0/m0 at the time of diagnosis and no clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial. * eastern cooperative oncology group (ecog) performance status 0-2 * prostate biopsy within 1 to 6 months (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the pet scan) 1. the biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an as. 2. at least 1 core must be mri-guided. exclusion criteria: * any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy) * chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis) * acute infections within the prostatic bed or lower urinary tract infections * participants have inadequate bone marrow, kidney, liver, heart, or lung function:
recording of physiological data via an optical sensor at the fingertip alongside with double auscultatory and pulse oximetry to evaluate the effectiveness of an optical blood pressure monitoring (obpm)

Conditions: Hypertension

Summary: the present study, obpm_calfree2024, with n = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with aktiia.product-g2c clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.


Eligibility criteria:
inclusion criteria: * subjects aged 21 to 85yo * subjects fluent in written and spoken french * subjects agreeing to attend the study visit and follow study procedures * subjects that have signed the informed consent form. exclusion criteria: * amputated index fingers * damaged/injured skin at index fingers * damaged/injured skin at wrists * subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation * subjects suffering from pathologies that systematically reduce peripheral perfusion including raynaud's disease, diabetes, renal dysfunctions (egfr \< 30ml/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula * pregnant women * polyneuropathy
chinese medicine wt for spinocerebellar ataxia type 3

Conditions: Ataxia, Spinocerebellar; Insulin-Like Growth Factor I; Medicine, Chinese Traditional

Summary: spinocerebellar ataxia type 3 (sca3) is one of autosomal dominant hereditary ataxias. standing imbalance, unsteady gait, dysmetria, fatigue, and depression would occur gradually. there are no effective treatment or palliative methods for patients in the present days. however, low-dose growth hormone, or its downstream product, insulin-like growth factor i (igf-1), may deter the progress of sca3 in transgenic mice. the main bioactive constituent among the chinese medicine wt possesses neuroprotective function against glutamate-induced toxicity, which is one major pathology of sca3. it promotes neurogenesis, and increases the protein expression of igf-1 in ischemic brains of rats. thus, we designed a randomized, double-blind trial for patients with sca3, if wt is a possible neuroprotective medicine. all the subjects will be recruited from changhua christian hospital. diagnosis is confirmed by gene test and magnetic resonance image by a neurologist. they will be assigned in random and double blind, prescribed with 3 grams concentrated powder of wt or placebo, twice a day, for 12 weeks. after the washout period of 4 weeks, there will be a crossover of placebo or wt for another 12 weeks. after that, another 4-week rest will be followed by the end of trial. check items in five check points include: 1. blood examination (serum igf-1, neurofilament light chain, mitochondria copy number, 8_ohdg, delta-ct), 2.neurological exam (scale for the assessment and rating of ataxia), 3. questionnaires (modified fatigue impact scale, epworth sleepiness scale), 4. handgrip strength test (which is correlated to igf-1 value in elderly), and 5. serum metabolites, . all the data will be disclosed after the end of trial. paired-t test or wilcoxon ranked sign test will be operated in spss.


Eligibility criteria:
inclusion criteria: * diagnosed as spinocerebellar ataxia type 3 exclusion criteria: * 1. using other chinese medicine or herbal medicine 2. allergic to chinese medicine or herbal medicine 3. pregnancy or breast feeding 4. with other major diseases, such as cancer, stroke, heart failure, or renal failure